
Mario D'angelo
HEAD OF SALES FOR ABRUZZO, MARCHE AND MOLISE

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About me
Site Manager J&J ATMPs | CAR-T Cell, Gene-Therapy Specialist
Education

Ospedale Pediatrico Bambino Gesù IRCCS
2019 -Certification of partecipation ISO 900:2015Intensive course regarding ISO 9000:2015 Quality Management System standard

ICmed
2019 -Training Course CAR-T SpecialistManagement of clinical trial in Cell Therapies, Site selection requirement, Quality system implementation tool, Monitoring and Auditing CAR-T Centre performance, post marketing activities

ICmed
2019 -Quality Manager in a specialised Healthcare Facility Training Course QualificationQuality, Risk and Safety in Healthcare Facility. Designing and implementing an organisation and document system. Improve management: indicators and errors, accidents and adverse event. Audit management

L.N.Age
2017 - 2018Clinical Reasearch AssociateCertification according to Italian ministry of health decree 15.11.2011Methodology and regulations of clinical trials; GCP and GMP with reference to the experimental drug; pharmacovigilance; monitoring tasks.

ISHEO
2017 - 2018Master of Science - MS Clinical Project ManagerDescriptive statistic, probablility theory and inference technique apllied to Clinical Trial.Budget management and reporting

Clinical Research Educational Service
2015 - 2015Clinical ResearchClinical Monitor: 40 hours theoretical/practical course according to Italian ministry of health decree 15.11.2011

Università degli Studi di Perugia
2004 - 2010Degree in Pharmaceutical Sciences and Tecnology PharmacyKnowledge of pharmaceutical and biochemical medicine, scientific knowledge and technologies, International and National pharmaceutical laws, quality and quantity analysis of medicines.

Catholic University Medical School
2023 - 2024Master Degree Level II Market Access- Analysis of the impact of a new drug or medical device on the health care system;- Preparing clinical and economic evaluations to determine reimbursement or cost-effectiveness of new or reformulated pharmaceutical agents; - Health outcomes research.

Università Cattolica del Sacro Cuore
2014 - 2015Master degree level II Clinical and pre-clinical development of drug300 hours on ethical, regulatory, scientific and technical aspects of the process of drugs development and the related clinical trials. Diploma-course Pharmatrain.

Università degli Studi di Perugia
-Pharmaceutical Sciences and Tecnology Qualification Examination Licensed Pharmacist
Universidad de Granada
2006 - 2007Programma Socrates-Erasmus Pharmacy
Il Sole 24 ORE Business School
2016 - 2017Master degree level II Health management400 hours on health and the macroeconomic context, grant management, organization of business precesses, HTA, Marketing and communication in healthcare facilities, e-health, Risk Management, Management Responsibility and health Security
Experience

Callier italia - Qvet - Trovet
Oct 2009 - Dec 2013HEAD OF SALES FOR ABRUZZO, MARCHE AND MOLISEI used to implement sales strategies, develop sales and distribution network, monitor sales and customer satisfaction. Head of payments: keeping track and reconciliation of of payments and orders

Pharmacy Mastrodicasa LTD
Jan 2011 - Nov 2011PHARMACIST - INTERN CHEMISTSales and preparation of prescription medicines

Ve.Pa.Farm LTD
Jan 2012 - Dec 2013PHARMACIST - WAREHAUSE MANAGEMENTI used to direct sales and purchasing, warehouse logistics management (goods register, stock taking, bookkeeping)

D'Eramo Pharmacy LTD
Jan 2014 - Oct 2015PHARMACISTMy responsibilities include the day to day running of the Pharmacy. Activities including support service to patients and identifying the right healthcare solution to their needs. Night shift

Ospedale Pediatrico Bambino Gesù
Oct 2015 - Mar 2020Pediatric onco-hematology and gene therapyPI Prof. Franco LocatelliPrimary point of contact for Sponsor and CRO involved in CAR-T and Gene Therapy Trial.Responsible for real-time issue resolution. Involved in study-specific management of treatment Slot assignement and in post-infusion safety Follow Up of enrolled patients.Management of cell and gene therapy supply chain.Collaborate with internal department and CRO to facilitate the onboarding/activation of new Study.Estabilished strong relationships with key external stakeholders in onco-hematology field.Develop cross-functional interactions with all department involved in Trial. Show less Pediatric onco-hematology and gene therapyPI Prof. Franco Locatelli Coordination of profit / no profit clinical studies in gene therapy- verifying of the procedures for the eligibility screening and testing of patients potentially were to be enrolled- interaction with SPONSOR / MONITOR / CRO / CENTRAL LABS - management of Pharmacovigilance (SAE / SUSAR)- accountability management of the investigational drug and / or medical devices (IWRS)- Activities with Phase I / II and III Pediatric hematology tumors studies Show less Pediatric onco-hematology PI Prof. Franco Locatelli/Dr. Giuseppe Maria MilanoActivities on:- data entry in CRFs - archival documents relating to CVs, agreement, financial disclosure documents, delegation of authority, signature logs, etc. (Trial Master File)- creating and management of clinical DB and DBMS storage, trend analysis of OS and DFS, submission of appropriate documentation to IEC / IRB to obtain the approval of clinical study or amendments - coordination with other Involved research groups for the management of surgical procedures diagnostic / imaging relating to the study protocol- coordination of activities for collection, processing, shipment of samples and biological material - Activities with Phase I / II and III Pediatric hematology tumors studies Show less
Car-T Cell /Gene Therapy Trial / Clinical Program
Jan 2018 - Mar 2020CLINICAL TRIAL COORDINATOR
Jul 2016 - Jan 2018CLINICAL DATA MANAGER
Oct 2015 - Jun 2016

Autonomo
Apr 2018 - May 2020CRA FreelanceResponsible for all aspects of study site monitoring including all type of visits, maintenance of study files and liaise with vendors. Phase I-IV studies.Review progress of projects and initiate appropriate actions to achieve target objectives.Report, write narratives and follow-up on serious adverse experiences.Recruitment of potential investigators, feasibilities studies.Internal and external audits: preparation and support to the sites during audits and with the audit issues resolution. Show less

ICON plc
Jun 2020 - Sept 2023CRA IISponsor-dedicated Janssen GCO (Pharmaceutical Company of Johnson and Johnson).Providing local management of a clinical trial in Onco-hematology field. Services/deliverables include operational oversite of assigned site from start-up trough to database lock and closeout activities.

Johnson & Johnson Innovative Medicine
Sept 2023 - nowSenior Site Manager Early Development ATMPs
Licenses & Certifications

Clinical Monitor - 40 hours theoretical/practical course according to Italian ministry of health decree 15.11.2011
Clinical Research Educational Service - CRES
Trainig in Good Clinical Practice in Clinical Trials TransCelerate Biopharma
CTC Policlinico Gemelli - Roma
Languages
- spSpagnolo
- inInglese
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